1-year Relapse-free Survival Rate
Primary
· up to 21.6 months
From enrollment to relapse or death
| Group | Value | 95% CI |
|---|---|---|
| Pembrolizumab | 14.3 | 9.0 – 19.5 |
Last reviewed · How we verify
NCT03322267
Adjuvant Pembrolizumab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma at High Risk of Recurrence
Completed
Phase 2
Results posted
Last updated 6 March 2026
What this trial tests
Phase 2 trial testing Pembrolizumab in Esophageal Squamous Cell Carcinoma in 26 participants. Completed in 30 January 2026.
Timeline
27 October 2018
Primary endpoint
31 January 2024
31 January 2024
30 January 2026
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 27 October 2018 |
| Primary completion | 31 January 2024 |
| Estimated completion | 30 January 2026 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →
Sponsor
National Taiwan University Hospital
Who can join
20 and older, any sex, with Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Time frame: I year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Pembrolizumab
Serious: 5/25 (20%)
Deaths: 17/25
Serious adverse events (4 terms)
| Reaction | System | Pembrolizumab |
|---|---|---|
| Infection | Infections and infestations | — |
| Colitis | Gastrointestinal disorders | — |
| Leucopenia | Blood and lymphatic system disorders | — |
| Pancreatitis | Gastrointestinal disorders | — |
Other adverse events (7 terms — click to expand)
| Reaction | System | Pembrolizumab |
|---|---|---|
| Leucopenia | Blood and lymphatic system disorders | — |
| Infection | Infections and infestations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Fatigue | General disorders | — |
| anemia | Blood and lymphatic system disorders | — |
| thrombocytopenia | Blood and lymphatic system disorders | — |
Most-reported serious reactions: Infection, Colitis, Leucopenia, Pancreatitis.
Data from ClinicalTrials.gov NCT03322267 adverse events section.
Sponsor's own description
In this study, participants with histologically diagnosed locally advanced esophageal squamous cell carcinoma who have received preoperative cisplatin-based chemoradiotherapy followed by surgery harbouring high risk of tumor recurrence will receive adjuvant cisplatin-based chemoradiotherapy followed by pembrolizumab. The primary study hypothesis is that adjuvant pembrolizumab will improve the 1-year recurrence-free survival rate compared to historical control.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Combination Options and Predictive Biomarkers of PD-1/PD-L1 Inhibitors in Esophageal Cancer.
Yang H, Wang K, Wang T, Li M, et al · · 2020 · cited 35× · PMID 32195194 · DOI 10.3389/fonc.2020.00300 -
Immune checkpoint inhibitors in esophageal squamous cell carcinoma: progress and opportunities.
Jiao R, Luo H, Xu W, Ge H. · · 2019 · cited 26× · PMID 31551657 · DOI 10.2147/ott.s214579 -
Current state of the art: immunotherapy in esophageal cancer and gastroesophageal junction cancer.
Li N, Sohal D. · · 2023 · cited 22× · PMID 37995002 · DOI 10.1007/s00262-023-03566-5 -
Radiotherapy combined with immune checkpoint inhibitors in locally advanced/metastatic esophageal squamous cell carcinoma: clinical trials, efficacy and future directions.
Jiang M, Hu Y, Lin G, Chen C, et al · · 2023 · cited 18× · PMID 37325652 · DOI 10.3389/fimmu.2023.1177085 -
Opportunities and challenges in combining immunotherapy and radiotherapy in esophageal cancer.
Zhang X, Cai X, Yan C. · · 2023 · cited 6× · PMID 37985502 · DOI 10.1007/s00432-023-05499-z -
Narrative review of pembrolizumab for the treatment of esophageal cancer: evidence and outlook.
Jin Z, Shen J, Wang C, Chen D, et al · · 2021 · cited 6× · PMID 34430630 · DOI 10.21037/atm-21-2804 -
A narrative review of the evolving role of immunotherapy in the management of esophageal and gastric cancer.
Madan A, Uronis HE, Strickler JH. · · 2022 · cited 5× · PMID 36092313 · DOI 10.21037/jgo-22-55 -
Challenges and perspectives for immunotherapy in oesophageal cancer: A look to the future (Review).
Lampis A, Ratti M, Ghidini M, Mirchev MB, et al · · 2021 · cited 5× · PMID 33846775 · DOI 10.3892/ijmm.2021.4930
Verify or expand the search:
- PubMed search for NCT03322267
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03322267 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
- Last refreshed: 6 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03322267.
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